Rafael J A Cámara1, Lukas Schwentner2,3, Thomas W P Friedl2, Miriam Deniz2, Visnja Fink2, Krisztian Lato2, Peter Widschwendter2, Brigitte Rack2, Wolfgang Janni2, Susanne Singer4, Inga Bekes2. 1. Institute for Medical Biometry, Epidemiology and Informatics, Medical Centre of the University of Mainz, Obere Zahlbacher Straße 69, 55131, Mainz, Germany. rafael@camara.li. 2. Department of Gynaecology and Obstetrics, University Hospital Ulm, Ulm, Germany. 3. GYNOVA, Praxis für Gynäkologie und Geburtshilfe, Reith bei Kitzbühel, Austria. 4. Institute for Medical Biometry, Epidemiology and Informatics, Medical Centre of the University of Mainz, Obere Zahlbacher Straße 69, 55131, Mainz, Germany.
Abstract
PURPOSE: In high-risk early breast cancer, adjuvant taxane-Gemcitabine combinations result in a recurrence-free survival similar to single-agent taxanes. However, haematologic toxicities and need for dose reductions are more frequent in combinations. Which option ultimately provides a better quality of life (QoL) is unknown. We compared the QoL curves before, during, and up to one year after three cycles of Fluorouracil-epirubicin-cyclophosphamide followed by three cycles of Docetaxel-Gemcitabine or Docetaxel. METHODS: Overall, 3691 women with recent R0-resection of a primary epithelial breast cancer participated in the nationwide SUCCESS A clinical trial. The centres sent QoL questionnaires of the European Organisation for Research and Treatment of Cancer before and up to 15 months after randomisation to Docetaxel-Gemcitabine versus Docetaxel. Multilevel analysis by chemotherapy arm estimated the QoL time curves, questionnaire return, and dropout. RESULTS: The combination caused one-point higher global QoL (95% confidence ±1; p = 0.05) and 1.1 lower odds of adherence to the outcome (95% confidence 1.0-1.1; p = 0.23) than the monotherapy. In both groups, a 10-point decrease during therapy preceded a 16-point increase after chemotherapy (p < 0.001). The secondary QoL outcomes showed transient superiority of the combination at the end of chemotherapy. Discontinuation from chemotherapy and its reasons were equal in both groups. CONCLUSIONS: While patients perceive a one-point QoL difference as meaningless, a six-point increase is clinically relevant for them. That is, both regimens cause the same relevant long-term QoL improvement. With the similar recurrence-free survival, the lower toxicity, and the shorter chemotherapy duration in mind, taxanes without Gemcitabine are the preference. This challenges previous recommendations supporting combinations.
PURPOSE: In high-risk early breast cancer, adjuvant taxane-Gemcitabine combinations result in a recurrence-free survival similar to single-agent taxanes. However, haematologic toxicities and need for dose reductions are more frequent in combinations. Which option ultimately provides a better quality of life (QoL) is unknown. We compared the QoL curves before, during, and up to one year after three cycles of Fluorouracil-epirubicin-cyclophosphamide followed by three cycles of Docetaxel-Gemcitabine or Docetaxel. METHODS: Overall, 3691 women with recent R0-resection of a primary epithelial breast cancer participated in the nationwide SUCCESS A clinical trial. The centres sent QoL questionnaires of the European Organisation for Research and Treatment of Cancer before and up to 15 months after randomisation to Docetaxel-Gemcitabine versus Docetaxel. Multilevel analysis by chemotherapy arm estimated the QoL time curves, questionnaire return, and dropout. RESULTS: The combination caused one-point higher global QoL (95% confidence ±1; p = 0.05) and 1.1 lower odds of adherence to the outcome (95% confidence 1.0-1.1; p = 0.23) than the monotherapy. In both groups, a 10-point decrease during therapy preceded a 16-point increase after chemotherapy (p < 0.001). The secondary QoL outcomes showed transient superiority of the combination at the end of chemotherapy. Discontinuation from chemotherapy and its reasons were equal in both groups. CONCLUSIONS: While patients perceive a one-point QoL difference as meaningless, a six-point increase is clinically relevant for them. That is, both regimens cause the same relevant long-term QoL improvement. With the similar recurrence-free survival, the lower toxicity, and the shorter chemotherapy duration in mind, taxanes without Gemcitabine are the preference. This challenges previous recommendations supporting combinations.
Entities:
Keywords:
Anthracyclines; Breast neoplasms; Gemcitabine; Quality of life; Toxoids
Authors: Amelie de Gregorio; Lothar Häberle; Peter A Fasching; Volkmar Müller; Iris Schrader; Ralf Lorenz; Helmut Forstbauer; Thomas W P Friedl; Emanuel Bauer; Nikolaus de Gregorio; Miriam Deniz; Visnja Fink; Inga Bekes; Ulrich Andergassen; Andreas Schneeweiss; Hans Tesch; Sven Mahner; Sara Y Brucker; Jens-Uwe Blohmer; Tanja N Fehm; Georg Heinrich; Krisztian Lato; Matthias W Beckmann; Brigitte Rack; Wolfgang Janni Journal: Breast Cancer Res Date: 2020-10-23 Impact factor: 6.466